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Training in Goal-directed Attention Regulation for Individuals With Brain Injury

Primary Purpose

Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
training in goal-directed attention regulation
brain health education
computer-assisted training in goal-directed attention regulation
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury focused on measuring attention, rehabilitation, training, functional MRI, executive function, brain injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • history of traumatic brain injury
  • greater than 1 week from injury
  • residual dysfunction related to attention and executive control

Exclusion Criteria:

  • aphasia
  • active illicit drug use
  • severe depression
  • contraindications to MRI scanning

Sites / Locations

  • VA Northern California Health Care System, Mather, CA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Goal-oriented Attention Regulation Training

Education

Technology-assisted Goal-directed Self-Regulation Training

Arm Description

training in goal-directed attention regulation

brain health education

computer-assisted training in goal-directed attention regulation

Outcomes

Primary Outcome Measures

Self-report
Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.

Secondary Outcome Measures

Change From Baseline to Post-training for Task Errors on a Functional Performance Measure
Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).
Change to Attention and Executive Functioning Composite Scores
Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3. Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning. The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time.

Full Information

First Posted
December 16, 2009
Last Updated
October 18, 2017
Sponsor
VA Office of Research and Development
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01035606
Brief Title
Training in Goal-directed Attention Regulation for Individuals With Brain Injury
Official Title
Plasticity in Brain Network to Enhance Cognitive Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Brain injuries affect the lives of numerous Veterans. This study examines how the brain is affected by injury and how rehabilitation training for attention dysfunction may change brain functioning.
Detailed Description
Traumatic brain injuries (TBI) are a leading cause of long-term disability among combat Veterans. The most common and persistent sequelae after TBI are cognitive-behavioral deficits in 'executive control' and 'attention' functions. Such abnormalities may directly contribute to poor long-term outcomes as well as impede rehabilitation of dysfunction in other cognitive and motor domains. Effective treatments would potentially make a major impact in improving functional outcomes, but consistently effective treatments are not available. The overall goal of this research is to improve the investigators' understanding of plasticity in brain function after TBI and to develop improved cognitive neurorehabilitation treatments. The intervention involves individual and group-based training in cognitive skills.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injury
Keywords
attention, rehabilitation, training, functional MRI, executive function, brain injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The design for Arms 1 and 2 was a cross-over design. Half the participants completed Arm 1 first and then crossed-over to Arm 2; the remaining half completed Arm 2 first and then crossed-over to Arm 1. Thus, all participants completed both Arm 1 and 2. Arm 3 represented a parallel study. Participants enrolled in this arm did not cross-over to any other condition.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal-oriented Attention Regulation Training
Arm Type
Experimental
Arm Description
training in goal-directed attention regulation
Arm Title
Education
Arm Type
Active Comparator
Arm Description
brain health education
Arm Title
Technology-assisted Goal-directed Self-Regulation Training
Arm Type
Experimental
Arm Description
computer-assisted training in goal-directed attention regulation
Intervention Type
Behavioral
Intervention Name(s)
training in goal-directed attention regulation
Intervention Description
training in goal-directed attention regulation
Intervention Type
Behavioral
Intervention Name(s)
brain health education
Intervention Description
brain health education workshops
Intervention Type
Behavioral
Intervention Name(s)
computer-assisted training in goal-directed attention regulation
Intervention Description
computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
Primary Outcome Measure Information:
Title
Self-report
Description
Responses to goal processing questionnaire relating to areas of personal goal-based functioning. This scale measured participants self-perceived changes to their cognitive and emotional functioning. Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved). Participants did not complete this measure after Arm 2.
Time Frame
5 Weeks (After completion of active trainings in Arm 1 and Arm 3)
Secondary Outcome Measure Information:
Title
Change From Baseline to Post-training for Task Errors on a Functional Performance Measure
Description
Participants completed a functional assessment task, the modified Multiple Errands Task (MET). The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period. Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules. Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3). Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).
Time Frame
5 weeks (After completion of Arm 1 and Arm 2)
Title
Change to Attention and Executive Functioning Composite Scores
Description
Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3. Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning. The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time.
Time Frame
5 weeks (After completion of Arm 1 and Arm 2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: history of traumatic brain injury greater than 1 week from injury residual dysfunction related to attention and executive control Exclusion Criteria: aphasia active illicit drug use severe depression contraindications to MRI scanning
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D'Esposito, MD
Organizational Affiliation
VA Northern California Health Care System, Mather, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Northern California Health Care System, Mather, CA
City
Sacramento
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21169860
Citation
Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2.
Results Reference
background
PubMed Identifier
21515904
Citation
Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541-54. doi: 10.1093/brain/awr067. Epub 2011 Apr 22.
Results Reference
result
Links:
URL
http://www.ncire.org
Description
Northern California Institute for Research and Education

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Training in Goal-directed Attention Regulation for Individuals With Brain Injury

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